Associate Scientist I – Biologics Drug Product Development
Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.
Gilead Sciences has an opportunity for an experienced candidate in our Biologics Drug Product Development group at our site in Oceanside, CA. We are seeking motivated, team-oriented individuals with scientific experience in laboratory work related to biologics.
Essential Duties and Job Functions:
A strong understanding of formulation and drug product process development for early and late stage biologics. Expected to perform hands-on experimentation by executing studies supporting formulation development, scale-down/-up experiments to define drug product process parameters, and to author protocols, summary reports, as well as sections of regulatory submissions.
Experience with a range of biologics modalities and delivery methods. Modalities could include antibodies, fusion proteins, bi-specifics, vaccines, lipid nanoparticles, etc. In addition, the candidate is expected to execute experiments evaluating IV infusion delivery methods using bags/bottles and syringe pumps, as well as evaluate subcutaneous injection delivery methods.
Experience in lyophilized drug product formulation development, process development, and related laboratory techniques, such as freezedrying microscopy, Karl-Fisher moisture analysis, and differential scanning calorimetry, is also preferred.
May contribute to the development of stability-indicating assays, such as opalescence and color assessment, sub-visible and visible particulate analysis, and container closure integrity.
Designs and executes developmental stability studies by employing a variety of biochemical and biophysical analytical techniques, such as HPLC, capillary electrophoresis, and/or spectroscopy methods, as well as conducts compatibility studies with primary drug container closure systems, such as vials and syringes, and in-use intravenous (IV) delivery systems. Participates or leads drug product technology transfers from process development to clinical and commercial manufacturing sites, serves on-site as a site technical representative for process scaleup studies and technical support during GMP operations. Authors tech transfer documentation defining the process and parameters, as well as reviews master batch records for accuracy.
Designs and executes scale-down/-up product impact studies for unit operations related to freeze/thaw, agitation and mixing, sterile filtration, vial and syringe filling, lyophilization cycle development, visual inspection, and transportation/shipping.
Has knowledge pertaining to global cGMP regulatory and guidance documents from the FDA, EMEA, ICH, US/EU Pharmacopeias, etc., related to drug product development, analysis, and manufacturing.
Be an effective communicator of ideas, project goals and results to crossfunctional departments/meetings in both written and presentation format. The candidate should have the ability to proactively identify issues, make key insights to data, and develop solutions in a collaborative multidisciplinary environment.
Candidates should be self-motivated, organized, and enjoy scientific investigation and thinking, as well as be familiar with the relevant technical literature.
Knowledge, Experience and Skills:
A minimum of 8+ years' industry experience with BS degree in related scientific discipline or 6+years' industry experience with MS degree in related scientific discipline.
Degree in Pharmaceutical Sciences, Chemical/Biochemical Engineering, Biochemistry or a related scientific discipline and relevant industry experience that demonstrates expertise in formulation process development as well as sustained excellence in performance and accomplishments that align to company goals.
Excellent communication skills (both verbal and technical) and interpersonal skills are required.
Demonstrates technical proficiency, scientific creativity, collaboration with others and independent thought in suggesting experimental design and research strategy.